510(k) K153448 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Passport Series Patient Monitors (Including Passport 8, Passport 12)
| Applicant | Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Mar 3, 2016 |
| Received | Nov 30, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153448
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 7, 2026 | Mindray DS USA, Inc. Passport Series Patient Monitor. Operator's Manuals: 8 / 12 / 12M / 17M / V Open, Classified |
MHX | None listed |
| Oct 7, 2026 | Mindray DS USA, Inc. cPM Series Patient Monitor. Operator's Manual: cPM 8/cPM 12 Open, Classified |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.